FDA issues a draft guidance on its Humanitarian Device Exemption (HDE) Program that clarifies the current review practices for the regulatory pathway....
Federal Register notice: FDA determines that Mutamycin (mitomycin) injectable, 5mg/vial and 20mg/vial, was not withdrawn for reasons of safety or effe...
Federal Register notice: FDA announces the renewal of its Pharmacy Compounding Advisory Committee for an additional two years.
FDA clears a Centinel Spine 510(k) to market its FLX Platform of integrated interbody and non-integrated interbody fusion devices.
FDA approves a Cellenkos IND to proceed with a Phase 1 clinical trial of CK0801, third-party cord blood-derived regulatory T cells, in patients with b...
Federal Register notice: FDA publishes a listing of recent OMB-approved information collections.
Federal Register notice: FDA announces the renewal of its Drug Safety and Risk Management Advisory Committee for an additional two years.
Federal Register notice: FDA announces the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee for an additional two years.